Product Safety Recalls

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KETOCONAZOLE Recall D-1065-2022

Description: Ketoconazole Cream, 2%, Net Wt 60 grams tube, Rx only, MFG: Nycomed Inc, NDC 0168-0099-60

KETOCONAZOLE Recall D-1065-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1065-2022
Event ID89646
BrandKETOCONAZOLE
Generic NameKETOCONAZOLE
ManufacturerKETOCONAZOLE
Original Package?1
Active SubstanceKETOCONAZOLE
Drug RouteTOPICAL
DistributionUSA nationwide.
Quantity6 tubes
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC0168-0099
Product NUIN0000175487 M0002083 N0000182141
Drug UPC0301680099156
Pharma Class (EPC)Azole Antifungal [EPC]
Pharma Class (CS)Azoles [CS]
Recall Initiation Date20220413
Report Date20220615
Classification Date20220609
Address9954 Maryland DriveDeep Run Iii Ste. 4000
Richmond, VA 23233
United States
Recalling FirmMckesson Medical-Surgical Inc. Corporate Office
Initial Notification Letter
Unique Ingredient IdentifierR9400W927I
Drug Application NumberANDA076294
Structured Product Labeling (SPL ID)b4ef7400-7e35-47f2-bd1c-3c5e15cc90ee
Structured Product Labeling (SPL Set ID)cad7c647-34a9-4e4e-83b3-8d78e58f588f
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